Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic profile of vincristine administered with imatinib for bcr-abl positive acute lymphoblastic leukemia (all) compared to that without imatinib for bcr-abl negative all

Conditions: Acute Lymphoblastic Leukemia

Summary: this study is characterizing the pharmacokinetics of vincristine using two different cohorts of patients. the first cohort includes patients with acute lymphoblastic leukemia (all) that are bcr-abl positive. this cohort of patients will receive vincristine along with imatinib in the induction chemotherapy regimen. the second cohort includes patients with all that are bcr-abl negative. this cohort of patients will receive vincristine without imatinib in the induction chemotherapy regimen. this study involves blood draws beginning on day 7 of the treatment protocol and these samples will be analyzed for pharmacokinetic parameters. imatinib and vincristine are both metabolized by the hepatic cyp 450 enzyme system. imatinib is an inhibitor of the system and co-administration of imatinib and vincristine has the potential to increase the blood level of vincristine. this could explain the increased level of neurotoxicity that is currently being seen with the co-administration of these two agents in the treatment of bcr-abl positive all.


Eligibility criteria:
inclusion criteria: * age \>/= 18 years * new diagnosis of bcr-abl positive all or bcr-abl negative all * receiving induction chemotherapy with the standard princess margaret hospital modified dfci protocol * will have a functioning central venous access catheter in-situ * agreeing to participate in the study and sign the informed consent form exclusion criteria: * concomitant use of other agents that inhibit hepatic cytochrome cyp3a4, as these drugs may alter vincristine and imatinib levels * elevated liver function tests: bilirubin \>1.5xuln or ast/alt \>2.5xuln, or documented history of chronic liver disease.
a dose-ranging study of mk-5442 in postmenopausal women with osteoporosis (mk-5442-001)

Conditions: Osteoporosis

Summary: the purpose of this study was to identify an appropriate dose of mk-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

Eligibility criteria:
inclusion criteria: * postmenopausal for at least 5 years * no history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy * agrees not to use medications for osteoporosis except medications associated with the study * areal bone mineral density (bmd) t-score \<-2.5 at one or more of the following 4 bmd sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 bmd sites. participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal bmd t-scores of \< -3.5 exclusion criteria: * unable to undergo dual-energy x-ray absorptiometry (dxa) scan due to obesity (ie, weight \>250 lbs) * use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months * use of intravenous bisphosphonates, strontium, or growth hormone at any time * use of phenytoin or heparin within 2 weeks prior to visit 1; use of raloxifene within 6 months prior to visit 1 * use of pioglitazone or rosiglitazone at study screening * use of estrogen ± progestin, in any form other than vaginal or topical application, for 6 months prior to study visit 1 * prior total thyroidectomy * human immunodeficiency virus (hiv)- positive or acquired immune deficiency syndrome (aids)-related illness * history of malignant cancer within 5 years of study screening, except for certain skin or cervical cancers * history of paget's disease and/or kidney stones * an active user of any illicit drug * history of or active alcohol abuse * participated in an investigational drug study within the past 30 days

Keywords: osteoporosis postmenopausal mk-5442
a new abdomen closure technology based on component separation: a prospective randomized controlled trial

Conditions: Fascial Closure

Summary: at present, open-type abdominal surgery is routine access into the abdomen. median incision is the common choice with open-type abdominal surgery. layered abdomen-closing is often used at the end-time of the surgery. there are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. the key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing. it's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. but the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia. based on this, we hypothesis that modified-cst applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing. in this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-cst will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.


Eligibility criteria:
inclusion criteria: * adult patients \>18 years of age * undergoing gastric cancer surgery * undergoing abdominal surgery first time * median upper abdominal incision applied (length of incision \> 5cm) * randomly select abdominal closure technique agreed by patients and family members exclusion criteria: * women who pregnant * coagulation disorders * undergoing immunological therapy * undergoing chemothearphy within 2 weeks before the surgery * undergoing abdominal radiotherapy within 8 weeks before the surgery * spirit disease patients * the expecting life span less than 48 hours * no guarantees to follow-up for 3 years * patients with poor compliance

Keywords: abdominal wound closure techniques layered closure component separation technique
early lung cancer detection using computed tomography

Conditions: Lung Cancer

Summary: early detection of lung cancer may improve treatment outcomes. risk factors have been identified, suggesting a population which might benefit from regular screening. lung cancer screening using low-dose computed tomography (ldct) has experienced a recent renaissance with reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. the purpose of this study is to evaluate the utility of lcdt for the early diagnosis of lung cancer in ontario.


Eligibility criteria:
inclusion criteria: 55 years or older at least 10 pack-year history of smoking general good health exclusion criteria: any prior cancers except non-melanotic skin cancer

Keywords: lung cancer eary diagnosis screening
study in subjects greater than 40 years of age with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a multicenter, phase iiib, randomized, double-blind, active-controlled, parallel-group, comparative study. the objectives of this study are: 1. to compare the efficacy of tiotropium 18 mcg once daily plus formoterol fumarate inhalation solution (ffis) 20 mcg twice daily to tiotropium 18 mcg once daily. 2. to obtain safety data on the use of tiotropium 18 mcg once daily plus ffis 20 mcg twice daily compared to tiotropium 18 mcg once daily.


Eligibility criteria:
inclusion criteria: * medical diagnosis of copd * current or prior history of cigarette smoking exclusion criteria: * medical diagnosis of asthma * significant condition or disease other than copd

Keywords: copd
effect of aspirin on abacavir-induced platelet reactivity in hiv-infected patients

Conditions: HIV-infected Patients

Summary: the specific research questions addressed in the present study are: * to investigate the impact of treatment with low-dose aspirin in hiv-1-infected patients treated with abc and test it would result in decreased in vivo platelet activation and platelet hyperreactivity * to investigate if aspirin has the same effects in hiv-infected as in hiv-uninfected patients.

highly active antiretroviral therapy (haart) may reduce the deleterious effects of hiv on the cardiovascular system by decreasing viral load and chronic inflammation; however some antiretrovirals enhance cardiovascular risk due to direct adverse effects on platelets or the endothelium. abacavir/lamivudine (abc/3tc) and tenofovir/emtricitabine (tdf/ftc) are the most widely used nucleoside reverse transcriptase inhibitor (nrti) associations in haart. abc has been initially considered as one of the most benign antiretroviral drugs due to a better metabolic profile than other nucleoside analogues, but since the d.a.d. study reported an association between the use of abc and an increase in cardiovascular risk there has been controversy around this drug. clinical evidence suggests that in vivo platelet activation and platelet hyperreactivity contribute to adverse cardiovascular events and hyperreactive platelets may transform a normal reparative response to a mild arterial injury into an unwanted thrombotic event. aspirin is the cornerstone in the prevention of atherothrombotic events, as it has been shown to be effective both in the primary and secondary prevention of mi (6), and its beneficial effects likely involve the modulation of inflammatory and immune pathways. but despite heightened awareness regarding elevated cvd risk among hiv-infected patients, aspirin or others antiplatelet therapy were markedly underprescribed among hiv-infected patients at risk for cvd events (7). based on this, the proposed study will assess whether low-dose aspirin, in well-characterized hiv-1-infected patients treated with abc, would result in decreased in vivo platelet activation and platelet hyperreactivity. moreover will be investigate if aspirin will have the same effects in hiv-infected as in hiv-uninfected patients.

Eligibility criteria:
inclusion criteria: * a viral load \<50 copies per millilitre * abc treatment for at least 6 months exclusion criteria: * age younger than 18 * nonsteroidal anti-inflammatory drug use in the past week (including aspirin), renal failure (creatinine clearance \<30 ml/min), platelet count \<100,000/microl, history of gastrointestinal bleeding within the last 6 months, presence of coexisting inflammatory disease, cancer, active bacterial or fungal infection, bleeding history, oral anticoagulant therapy and allergy to aspirin
capecitabine or endocrinotherapy as a maintenance therapy regimen at least 2nd line in hormone receptor positive and her2 negative metastatic breast cancer

Conditions: Breast Cancer

Summary: a single-site study about the efficacy of sequential monotherapy: capecitabine vs. endocrine therapy, in metastatic breast cancer patients with hr-positive \& her2-negative after capecitabine-base chemotherapy.

capecitabine-base chemotherapy must be ≥second-line therapy

Eligibility criteria:
inclusion criteria: * signed informed consent * the age is above 18 years of age, \<70 years old * hr-positive \& her2-negative * metastatic breast cancer,incurable. * for recurrent or metastatic lesions has had at least 1 but no more than 3 kinds of chemotherapy, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy will been the first-line treatment for metastatic lesions * no prior use of capecitabine therapy or the use of capecitabine treatment was effective, and the efficacy evaluation was cr/pr/sd more than 6 months. * eastern cooperative oncology group performance status (ecog ps)=0\~1 * the basic function of normal bone marrow * functions of liver and kidney is normal * expectation of life is more than 3 months * agreed to take contraceptive measures during treatment exclusion criteria: * previous toxicity was not recovered to 0-1 degrees * central nervous system metastasis * pregnancy or lactation * there are uncontrolled infection, myocardial infarction, thrombosis, etc. * there are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease; * researchers believe that is not suitable for the study * patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix; * bilateral breast cancer * capecitabine was ineffective in past treatment

Keywords: therapy capecitabine breast cancer
a study evaluating the bioavailability of two formulations of linifanib and food effect on pharmacokinetics of linifanib in subjects with advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: a pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.

this study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization. subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Eligibility criteria:
inclusion criteria 1. age is greater than or equal to 18 years. 2. subject must have a histologically or cytologically confirmed non-hematologic malignancy other than hepatocellular carcinoma (hcc). 3. eastern cooperative oncology group (ecog) performance score of 0-2. 4. subject must have adequate bone marrow, renal and hepatic function as follows: * bone marrow: absolute neutrophil count (anc) \>= 1,500/mm3 (1.5 x 109/l); platelets \>= 75,000/mm3 (75 x 109/l); hemoglobin \>= 9.0 g/dl (1.4 mmol/l) * renal function: serum creatinine \<= 2.0 mg/dl (0.81 mmol/l); * hepatic function: ast and alt \<= 1.5 x uln unless liver metastases are present, then ast and alt \<= 5.0 x uln; bilirubin \<= 1.5 mg/dl (0.026 mmol/l) 5. subject must have partial thromboplastin time (ptt) \</= 1.5 x upper limit of normal ( uln) and international normalized ratio (inr) \</= 1.5. exclusion criteria 1. subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. in addition subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy. 2. subject has undergone major surgery within 21 days of period 1, study day 1. 3. subject has untreated brain or meningeal metastases. subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to study day 1, period 1). 4. current enrollment in another clinical trial.
comparison of the effect of online physical exercise and computerized cognitive stimulation in patients with alzheimer's disease

Conditions: Alzheimer Disease; Telerehabilitation; Online Physical Exercise; Computerized Cognitive Stimulation; Covid-19 Pandemic

Summary: our aim has been determined to investigate the effect of physical exercise alone and in combination with cognitive exercise, on cognitive, physical function and quality of life in individuals with alzheimer's disease during the covid-19 pandemic period.


Eligibility criteria:
inclusion criteria: * ≥ 65 years and older * diagnosed with ad according to dsm-iv diagnostic criteria by a neurologist, * moca ≥ 13 * clinical dementia rating scale \< 2 * having sufficient wireless support or telephone connection where the person lives * who gave consent to participate in the study * no history of any neurological or orthopedic injury that could prevent participation in the study and affect functional mobility. exclusion criteria: * geriatric depression scale score \> 11 * various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) * clinically significant aphasia (must be able to understand the therapist's commands) * significant visual or sensory impairment * moca \< 13 * having a severe musculoskeletal disorder * having paralysis * impaired balance * the presence of severe lung and heart disease

Keywords: alzheimer's disease telerehabilitation physical exercise computerized cognitive stimulation covid-19 pandemic cognitive stimulation online physical exercise alzheimer disease
soy-based meal replacement in helping women with stage i, stage ii, or stage iii breast cancer in complete remission lose weight

Conditions: Breast Cancer; Obesity

Summary: rationale: a diet using a soy-based meal replacement may help survivors of breast cancer lose weight and improve their quality of life. purpose: this clinical trial is studying how well a soy-based meal replacement works in helping women with stage i, stage ii, or stage iii breast cancer in complete remission lose weight.

objectives: * determine the ability to recruit survivors of estrogen receptor/progesterone receptor (er/pr)-negative stage i-iii breast cancer to participate in a 3-month, soy-based, meal-replacement (almased®) weight loss intervention. * assess the patient's ability to adhere to this intervention protocol. * measure changes in anthropometrics (body weight, bioelectrical impedance, waist circumference) and biomarkers (serum levels of glucose, insulin, highly specific c-reactive protein, insulin-like growth factor, insulin-like growth factor binding protein-3, lipids). * measure changes in health-related quality of life. outline: this is a prospective, longitudinal, pilot study. patients undergo goal-oriented, cognitive-behavioral therapy comprising group counseling weekly for 3 weeks and individual counseling once a month. weight loss interventions include behavioral techniques, dietary modification (using a portion-controlled diet and soy-based meal-replacement \[almased®\] once or twice daily), physical activity (≥ 15 minutes per day, 6 days a week), and social support. weight loss is monitored weekly and patients complete daily logs of dietary intake and physical activity. therapy continues for 12 weeks. health-related quality of life is assessed at baseline and then weekly for 12 weeks. patients undergo blood draws at baseline and at 12 weeks for analysis of c-reactive protein, glucose, insulin, insulin-like growth factor (ilgf), and ilgf-binding protein-3. projected accrual: a total of 25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * previously diagnosed stage i-iii breast cancer currently in complete remission * completed treatment for breast cancer ≥ 6 months ago * free of disease at last clinic visit * body mass index ≥ 27 * hormone receptor status * estrogen receptor (er)/progesterone receptor (pr) negative patient characteristics: * female * menopausal status not specified * no history of soy allergies * no uncontrolled blood pressure * no uncontrolled hyperthyroidism or hypothyroidism * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no diabetes mellitus (type 1 or 2) * no medical, psychiatric, or behavioral factors that would preclude study participation * no definite plans to move out of the area during the study period prior concurrent therapy: * see disease characteristics * no concurrent medications for weight loss * no concurrent treatment for er/pr-negative disease

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer obesity
clinical scenarios and pathophysiology of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) remains the most common sustained cardiac arrhythmia with prevalence and incidence continuously increasing worldwide. current guidelines propose an etiological, symptom-based classification of the arrhythmia and mainly focused on its duration with consequent rhythm or rate-control strategies. moreover, risk scores for atherothrombotic systemic or hemorrhagic events related to atrial fibrillation are principally based on patients cardiovascular history and risk factors. this approach do not consider relevant pathophysiological aspects that may play a pivotal role in triggering or perpetuating the arrhythmia, especially at its first occurrence. at this point, a crucial step would be deeply investigating af clinical and pathophysiological features to guide a tailored diagnostical and therapeutic approach. indeed, early recognition and proper characterization of triggers, substrates, autonomic system imbalance and modulating factors (drugs, electrolytes, etc) are of the utmost importance for af care and management. therefore, this large scale prospective observational study aims to evaluate clinical and pathophysiological features of patients with symptomatic and asymptomatic atrial fibrillation in different scenarios to understand possible distinctive characteristics warranting a personalized approach to the arrhythmia.


Eligibility criteria:
inclusion criteria: * patients with electrocardiographic diagnosis of atrial fibrillation (new onset, paroxysmal, persistent, long standing persistent and permanent) admitted to the emergency room and/or cardiology department /ambulatory care center of our hospital * age \>18 years old * patients who can give their written informed consent. exclusion criteria: * age \<18 years old * patients who cannot give their written informed consent.

Keywords: atrial fibrillation pathophysiology triggers substrates autonomic system
comparison of two lidocaine administration techniques

Conditions: Pain

Summary: the objective of our study is to determine if technique of lidocaine administration can decrease pain perception. hypothesis: there will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.

this is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. subjects will be approached and consented to participate in the study. they will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. an investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.

Eligibility criteria:
inclusion criteria: * adult patients refered to the university of chicago medical centers procedure service for a planned medical procedure requiring local injection of lidocaine. exclusion criteria: * patient who lack decisional capacity to consent * patients who lack the ability to answer questions in english using pain scales

Keywords: procedural
long-term, extension study of ds-5141b in patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with ds-5141b in patients with dmd who have completed ds5141-a-j101.


Eligibility criteria:
inclusion criteria: * has competed a study of ds5141-a-j101 exclusion criteria: * significant safety issues in a study of ds5141-a-j101 * patient who does not consent to use appropriate contraception * patient not appropriate to participant in the study as determined by the investigator

Keywords: duchenne muscular dystrophy dmd oligonucleotides, antisense exon skipping ds-5141b